Trial Information
Perioperative Ketorolac in High Risk Breast Cancer Patients With and Without Inflammation. A Prospective Randomized Placebo-controlled Trial.
Inclusion Criteria:
Written informed Consent age : 18-85 years weight: 50-100 kg Neutrophils / Lymphocytes
ratio >4 and/or "triple negative" histological status and/or Positive lymph nodes
Exclusion Criteria:
Previous cancer (behalf of basocellular skin cancer and in situ uterine cervix cancer) Non
compliance or refusal of the protocol Positive Pregnancy test Childbearing or
breastfeeding mothers Contra-indication for NSAIDs NSAIDs intake in the 5 days before
randomisation NSAIDs use planned in the 30 days after randomisation Non curative surgery
(T4 or M1 tumor classification )
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Effect of ketorolac on recurrence-free survival
Outcome Description:
2 years for the primary analysis + 3 additional years for secondary analysis
Outcome Time Frame:
5 years
Safety Issue:
No
Principal Investigator
Patrice Forget, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Cliniques universitaires Saint-Luc
Authority:
Europe : EMEA
Study ID:
KBCtrial
NCT ID:
NCT01806259
Start Date:
February 2013
Completion Date:
March 2018
Related Keywords:
- Curative Breast Cancer Surgery
- Inflammatory Positive/Negative Status
- Pre Surgical Incision Administration
- Breast Neoplasms